PDA New England Chapter - Presentations

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Chapter Event Calendar

July 2008

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Presentations

NEPDA Sage Rapid Micro Environmental Monitoring (4.85 MB)
March 12, 2008

NEPDA Harris Cleanroom Decontamination (1.21 MB)
March 12, 2008

NEPDA Morris and Manley TR22 (1.48 MB)
March 12, 2008

NEPDA Agalloco TR22 (893 KB)
March 12, 2008

PDA New England Chapter Meeting (2.27 MB)
January 23, 2008

Steam Sterilization and the 2007 Revision of PDA Technical Report 1 (1.39 MB)
November 14, 2007 Speakers: Don Drew and Mike Fingers

NEPDA TR40 Sterilizing Gas Filtration (247 KB)
June 13, NEPDA TR40 Sterilizing Gas Filtration, Leesa McBurnie

NEPDA TR26 Sterilizing Liquid Filtration (519 KB)
June 13, NEPDA TR26 Sterilizing Liquid Filtration, Jerold Marti

The story behind the story ! What the PDA Technical Report 39 is all about (1.23 MB)
April 11, 2007 PDA New England Chapter presentation: "The story behind the story ! What the PDA Technical Report 39 is all about" by Sarvang Mishra, Senior Engineer, Wyeth

Global Cold Chain Regulations Influencing Storage, Handling, and Distribution of Clinical Trial Materials (227 KB)
April 11, 2007 PDA New England Chapter presentation: "Global Cold Chain Regulations Influencing Storage, Handling, and Distribution of Clinical Trial Materials" by Henry Ames, Director of Strategic Marketing, Sensitech

NEPDA Newsletter Volume 1 (222 KB)

Global Validation Requirements: The Principles of ICH, FDA, USP, Ph. Eur., JP (1.36 MB)
February 15, 2007 PDA New England Chapter on "Global Validation Requirements: The Principles of ICH, FDA, USP, Ph. Eur., JP" by Susan Schniepp, Quality Manager, Hospira, Inc.

Multi-Product Biopharmaceutical Manufacturing Facilities (179 KB)
November 08, 2006 PDA New England Chapter "Multi-Product Biopharmaceutical Manufacturing Facilities" by E Hoglund.
This presentation will point out, at a high level, things that we have done, or are working towards, or even things we wish we had done.

Selection of a Contract Aseptic Fill/Finish Manufacturer (164 KB)
January 01, 2006 PDA New England Chapter "Selection of a Contract Aseptic Fill/Finish Manufacturer" by John Dobiecki.

May 17, 2006 PDA Chapter Dinner Seminar on FDA Inspections.
Responding to a Form 483 or Warning Letter by Mark Lookabaugh (4.39 MB)
cGMP Pitfalls in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection by Michelle Sceppa (53 KB)
FDA's High Risk Drug & Systematic Approach to Inspections by Stephen Souza. (100 KB)

February 8, 2006 PDA Chapter Dinner Seminar on “Rapid Microbial Methods”
The Growth Direct Test: A Rapid Non-Destructive Method for Microbial Enumeration”, by Don Straus, Ph.D., from Genomic Profiling Systems, Inc.
“Identification of Microorganisms Using Comparative DNA Sequencing” by Michael Waddington, from Accugenix, Inc. (869 KB)

The Extra Work that Goes into Building a Manufacturing Facility When it is FDA-Regulated (389 KB)
April 20, 2005 PDA Chapter Dinner Seminar on Biotechnology as it relates to Genzyme's Allston Landing Manufacturing Facility:
"The Extra Work that Goes into Building a Manufacturing Facility When it is FDA-Regulated" by Jorge Ferreira, Director of Aseptic Processing and Fill/Finish Technologies for Washington Group International

An Ongoing Program to Assess Key Quality Elements at Genzyme by Todd Snell, Associate Director of Corporate Quality for Genzyme (431 KB)

Strategies for Monitoring and Troubleshooting Biopharmaceutical Operations by Jack Prior, Associate Director of Technical Services for Genzyme. (1.26 MB)

Visual Inspection of Injectable Products: More Than Just Sorting Good from Bad (1.54 MB)
Feb. 9, 2005 PDA New England Chapter Dinner Seminar on "Visual Inspection of Injectable Products: More Than Just Sorting Good from Bad" by John G. Shabushnig, PhD, Senior Manager, Pfizer Global Quality Technical Services.

Dec 8, 2004 PDA New England Chapter Dinner Seminar on " Process Analytical Technologies (PAT): , "The Harmonized PAT Solution: Application of Risk-Based Tools & Process Analytical Technology Strategies in Pharmaceutical Product Manufacture" by Jeffrey A. Priem, Principal Consultant, Barnett International (PAREXEL Consulting)" (773 KB)

Dec 8, 2004 PDA New England Chapter Dinner Seminar on "Process Analytical Technologies (PAT): "PAT & Risk-Based Initiatives: Doing the Business [a European Perspective]" by Cliff Campbell, CC&A Ltd." (162 KB)

Oct 1, 2004 PDA New England Chapter Workshop on "Development and Commercialization of Combination Products, The Commercialization of an Iontophoretic Drug Delivery System, by George M. Baskinger, Associate Director Regulatory Affairs, Vyteris" (196 KB)

Oct 1, 2004 PDA New England Chapter Workshop on "Development and Commercialization of Combination Products, A Drug-Eluting Stent Case Study: TAXUS™ Express2™ - From Development to Approval, by Kathleen M. Miller, Program Manager Drug Delivery, Boston Scientific" (4.15 MB)

Oct 1, 2004 PDA New England Chapter Workshop on "Development and Commercialization of Combination Products, Update, Regulatory Considerations in Approval of Combination Products, by Mark Kramer, Director Office of Combination Products, FDA" (175 KB)

May 4, 2004 PDA New England Chapter Meeting Presentation, "Sterile packaging of liquid
pharmaceuticals - Using rommelag bottelpack blow-fill-seal machines", by Mohammad Sadeghi, V.P. R&D Holopack International Corp. (2.9 MB)

May 4, 2004 PDA New England Chapter Meeting Presentation, "The Evolution of a New Disposable Filling Technology for Sterile Pharmaceuticals", by Jim Furey, Product Manager Millipore Corporation (1,019 KB)

February 2004 PDA New England Chapter Meeting Presentations, "Corrective and Preventive Actions — A Five Step Approach" by Tonya White-Salters, AVECIA (213 KB)

The Biogen Idec Approach to Managing Corrective and Preventive Action by Michael J Cross, BIOGEN IDEC (278 KB)

Disinfectant Regulation, Technologies, Sterility and Validtion
December 2003 PDA New England Chapter Meeting Presentation, "Disinfectant Regulation, Technologies, Sterility and Validtion" by Jim Polarine, MA, STERIS (955 KB)

Approaching Compliance with 21 CFR Part 11
September 2003 PDA New England Chapter Meeting Presentation, "Approaching Compliance with 21 CFR Part 11" by Alexander Buck, FORMATECH (148 KB)